| Project Title | Metabolic Effects of Second Generation Antipsychotics in Youth, Subprojects 1, 2, and 3 |
| Date Posted | Thursday, February 1, 2018 |
| Status | Complete |
| Deliverables | |
| Related Links | |
| Description | Subprojects 1 and 2 Protocol-based one-time assessment of the association between use of second generation antipsychotics (SGAs) in youth and adverse metabolic effects, including type 2 diabetes and the metabolic syndrome. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed. The Mini-Sentinel Operations Center posted this protocol for public comment from September 11, 2013, through September 25, 2013. A revised version was approved for implementation by FDA on November 21, 2013. A log of changes is included in the revised protocol. These projects have been completed; the final project reports were posted on July 31, 2014. Subproject 3 Protocol-based one-time assessment to determine the average change in body mass index (BMI) z-score among youth initiating monotherapy treatment with olanzapine, quetiapine or risperidone compared to aripiprazole between baseline (treatment initiation) and: (i) 12 weeks (+/- 2 weeks), and (ii) 52 weeks (+/- 8 weeks) in the Mini-Sentinel Distributed Database (MSDD) population. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed. The Mini-Sentinel Operations Center posted this final draft protocol for public comment from October 31, 2014, through November 14, 2014. The public comment period is now closed. A revised version was approved for implementation by FDA on January 14, 2016. A log of changes is included in the revised protocol. This project has been completed; the final project report was posted on February 2, 2018. |
| Medical Product | aripiprazole olanzapine quetiapine risperidone second generation antipsychotic (SGA) |
| Health Outcome | metabolic syndrome type 2 diabetes mellitus weight gain |
| Population / Cohort | Projects 1-2: All individuals 2-24 years of age; Project 3: All individuals 2-18 years of age |
| Time Period | Projects 1-2: 2001-2005; Project 3: 2006-2012 |
| Assessment Type | Safety Analyses |
| Study Type | Protocol/Surveillance Plan |
| Workgroup Leader(s) | Subprojects 1 and 2 Tobias Gerhard PhD, MSc; Rutgers University Institute for Health, New Brunswick, NJ Marsha Raebel PharmD; Kaiser Permanente Colorado, Denver, CO Subproject 3 Ann W. McMahon MD, MS; Office of Pediatric Therapeutics, Office of the Commissioner, FDA, Silver Spring, MD Robert Penfold PhD; Group Health Research Institute, Seattle, WA Diqiong Xie PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD
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| Workgroup Members | Melissa L Andersen MSc; J. Gene Hart MSc; Susan Shortreed PhD; Group Health Research Institute, Seattle, WA Susan Andrade ScD; Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA William Bobo MD, MPH; Vanderbilt University School of Medicine, Nashville, TN Chadi Calarge MD; Jess Fiedorowicz MD, PhD; University of Iowa, College of Medicine, Iowa City, IA Christoph Correll MD; Stephen Crystal PhD; Rutgers University Institute for Health, New Brunswick, NJ Kristin Goddard MPH; Susan Shetterly MS; Kaiser Permanente Colorado, Denver, CO Christine Y. Lu PhD, MSc; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA Ali Mohamadi MD; Simone Pinheiro ScD, MSc; Marsha Reichman PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD Zhiying You MD, PhD; University of Alabama at Birmingham, Birmingham, AL |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CDER |
